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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device humidifier, respiratory gas, (direct patient interface)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 3
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 11
FLEXICARE MEDICAL LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 3
PERMA PURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
  1.  K180474  TNI softFlow 50
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 2
VINCENT HEALTHCARE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 918 918
2019 894 894
2020 1188 1198
2021 1510 1511
2022 749 749
2023 716 736
2024 500 505
2025 1755 1759

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3299 3299
Defective Alarm 1100 1102
Material Split, Cut or Torn 592 597
Leak/Splash 470 476
Crack 464 468
Detachment of Device or Device Component 414 425
Break 398 413
Fluid/Blood Leak 368 369
Insufficient Heating 307 307
Failure to Power Up 186 186
Device Alarm System 138 138
Gas/Air Leak 130 130
Melted 104 104
Mechanical Problem 91 92
Complete Loss of Power 83 83
Adverse Event Without Identified Device or Use Problem 65 65
Disconnection 61 63
Power Problem 58 58
Stretched 52 53
Temperature Problem 51 51
Overfill 51 51
Insufficient Information 47 47
Material Puncture/Hole 42 42
Therapeutic or Diagnostic Output Failure 32 34
Device Dislodged or Dislocated 32 32
Overheating of Device 31 32
Use of Device Problem 29 29
Infusion or Flow Problem 27 27
Defective Component 27 27
No Audible Prompt/Feedback 27 27
Obstruction of Flow 25 25
Moisture or Humidity Problem 20 20
Connection Problem 20 21
Unexpected Shutdown 20 20
Loose or Intermittent Connection 20 20
Improper Flow or Infusion 19 19
Defective Device 18 18
Device Displays Incorrect Message 18 18
Output Problem 17 17
Misconnection 17 17
Improper or Incorrect Procedure or Method 17 17
No Apparent Adverse Event 16 16
No Flow 16 18
Protective Measures Problem 15 15
Fire 14 14
Difficult to Open or Close 14 14
Material Integrity Problem 14 14
Unintended Movement 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Loss of Power 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5204 5238
No Patient Involvement 1279 1279
No Known Impact Or Consequence To Patient 920 922
No Consequences Or Impact To Patient 319 320
Low Oxygen Saturation 306 308
Insufficient Information 116 117
Death 25 25
Hypoxia 19 19
Burn(s) 16 16
No Information 14 14
Bradycardia 10 10
Partial thickness (Second Degree) Burn 10 10
Cardiac Arrest 10 10
Superficial (First Degree) Burn 7 7
Respiratory Distress 7 7
Cough 6 6
Unspecified Respiratory Problem 6 6
Obstruction/Occlusion 6 6
Dyspnea 5 5
Aspiration/Inhalation 5 5
Tachycardia 4 4
Pneumonia 4 4
Discomfort 4 4
Viral Infection 4 4
Cancer 4 4
Airway Obstruction 4 4
Respiratory Arrest 3 3
Respiratory Failure 3 3
Full thickness (Third Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 3 3
Blister 2 2
Burn, Thermal 2 3
Asthma 2 2
Pressure Sores 2 2
Skin Inflammation/ Irritation 2 2
No Code Available 2 2
Pain 2 2
Distress 2 2
Increased Respiratory Rate 2 2
Fibrosis 1 1
Irritability 1 1
Inadequate Pain Relief 1 1
Headache 1 1
Bacterial Infection 1 1
Respiratory Insufficiency 1 1
Myocardial Infarction 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Ventilator Dependent 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II Oct-15-2025
2 Fisher & Paykel Healthcare, Ltd. II May-15-2024
3 Hamilton Medical AG III Jul-14-2022
4 TELEFLEX MEDICAL INC I Feb-07-2020
5 Vapotherm II Mar-17-2023
6 Vyaire Medical I Jan-24-2018
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